Table 1.

Proposed classification of social media data by potential value to pharmacovigilance

Area	Value proposition	Examples
Reporting and communication	Direct interaction between interested parties Increased awareness on part of the MAH, HA patient	Provides tools to report ADRs—company product websites, Medwatch, Yellow Card Sharing experiences and practices: communities of HCPs; communities of patients Two-way communication: risk communication; information sharing
Signal detection	Find rare events not often reported through spontaneous reporting to HAs and pharma companies Find medical side effects earlier than in other systems across a broad spectrum Alleviate underreporting known to occur in spontaneous systems	Primary signal detection tool alongside traditional (spontaneous) sources, across all products and events
Niche PV in pre-specified areas	Find new information in specific niche areas underrepresented in current monitoring systems May be used as a primary tool for safety signal detection in certain pre-defined narrow areas (in contrast to broad-based safety monitoring across all products/events where social media are not value-added)	Exposure during pregnancy Abuse Misuse Low exposure, e.g., orphan drugs
Signal evaluation	Use for strengthening of hypotheses emerging from other systems Provide additional insight into safety issues identified through other means	Ad-hoc inspection of social media posts after a safety signal has been found in other sources
Quality of life	Find areas of patient and HCP concern that are not necessarily medically serious, but that have a significant impact on quality of life	Insomnia Stress Depressed mood

ADR adverse drug reaction, HA Health Authority, HCP health care provider, MAH Marketing Authorisation Holder, PV pharmacovigilance